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OPERATOR'S MANUAL

1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT)

For proper functioning, the device requires connection to a personal computer (PC) and the relative software. For the

minimum requirements of the PC, refer to the paragraph TECHNICAL DATA.

The PC is not included with the device. It is recommended to only use a PC compliant to the IEC 60950-

1:2007 standards for information technology devices.

1.4. STANDARDS AND REGULATIONS

The system has been designed to meet the following standards:

- Directive 93/42/EEC and subsequent amendments and additions

(dir. 2007/47/EC) - Medical Devices Directive;

- Directive 2006/42/EEC - Machinery Directive.

Technical Standards:

IEC 60601-1:2005 + A1:2012
IEC 60601-1-2:2014
IEC 60601-1-3:2008 + A1:2013
IEC 60601-2-63:2012 + A1:2017
IEC 60601-1-6:2010 + A1:2013
IEC 62366:2007 + A1:2014
IEC 62304:2006
IEC 60825-1:2014

1.5. CLASSIFICATIONS

The system is classified as Class I and Type B as regards safety according to IEC 60601-1.

The system is classified as a Class IIB medical electrical X-ray device in accordance with Medical Device Directive

93/42/EEC and subsequent amendments.

Содержание GiANO HR

Страница 1: ...97050977 Rev 02 2018 11 NewTom GiANO HR EN ...

Страница 2: ...2 OPERATOR S MANUAL EN ITALIANO ...

Страница 3: ...25 4 CONTROL PANEL 27 4 1 CONTROL PANEL ONBOARD THE MACHINE 27 4 2 CONTROL CONSOLE 28 4 3 PUSHBUTTON PANEL ON TELE X RAY ARM 28 4 4 X RAY EMISSION REMOTE CONTROL 28 4 5 PERFORM A SIMULATION DUMMY RUN 30 4 6 PARKING POSITION 30 5 PERFORMING A 2D X RAY EXAMINATION 31 5 1 STARTING THE SYSTEM 31 5 2 SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE 32 5 2 1 2D EXAMINATIONS AVAILABLE 32 5 2 2 SELECTIN...

Страница 4: ...68 7 2 3 3 FRONT VIEW OF BOTH CONDYLES 2 IMAGES 68 7 2 3 4 FRONT VIEW OF A SINGLE CONDYLE 3 IMAGES 68 7 2 4 SIN EXAMINATIONS 69 7 2 4 1 FRONT VIEW 69 7 2 4 2 LATERAL VIEW 69 7 2 5 BITEWING EXAMINATIONS 69 7 2 6 DENTITION EXAMINATIONS 70 7 2 7 CEPH EXAMINATIONS 70 7 2 7 1 CEPH AP PA 70 7 2 7 2 CEPH LATERAL 71 7 2 7 3 CEPH CARPUS 72 8 TECHNICAL DATA 73 8 1 ELECTRICAL CHARACTERISTICS 73 8 2 RADIOLOGI...

Страница 5: ...EN OPERATOR S MANUAL 5 10 1 8 TRANSLATION 85 10 1 9 SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE 85 11 INSPECTION AND MAINTENANCE 86 11 1 USER INSPECTION 86 11 2 TECHNICAL MAINTENANCE 87 ...

Страница 6: ...om GiANO HR allows the following projections standard or panoramic views for paediatric patients PAN complete or partial views of the teeth selected by the user DENT front and side views of maxillary sinuses SIN side and posteroanterior views of the temporomandibular joints TMJ from different angles If equipped with tele X ray arm CEPH NewTom GiANO HR allows the following projections cephalographi...

Страница 7: ...is possible to contact the local distributor 1 1 DESCRIPTION OF THE MANUAL This manual is an essential consultation tool and contains important information and instructions for the use of the X ray system and its relevant controls These instructions describe how to properly and safely use the digital X ray system Carefully read and familiarise yourself with the entire contents of the manual before...

Страница 8: ...rves the right to make changes without prior notice The information technical specifications and illustrations contained in this publication are not binding The Manufacturer reserves the right to make technical modifications and improvements without modifying these instructions All the registered trademarks and the product names mentioned are the property of the respective owners Carefully read th...

Страница 9: ... been designed to meet the following standards Directive 93 42 EEC and subsequent amendments and additions dir 2007 47 EC Medical Devices Directive Directive 2006 42 EEC Machinery Directive Technical Standards IEC 60601 1 2005 A1 2012 IEC 60601 1 2 2014 IEC 60601 1 3 2008 A1 2013 IEC 60601 2 63 2012 A1 2017 IEC 60601 1 6 2010 A1 2013 IEC 62366 2007 A1 2014 IEC 62304 2006 IEC 60825 1 2014 1 5 CLASS...

Страница 10: ... necessary to read the user s manual before using the device This symbol in the manual identifies the paragraphs containing important information on the use of the product Applied part of type B according to IEC 60601 1 Equipment compliant with directive 93 42 EEC as amended Notified body IMQ spa Ionizing radiation warning symbol Class 1 LASER radiation warning symbol Crushing hazard Disposal symb...

Страница 11: ...upervision of a Qualified Expert The room where the system is installed must exclusively be for medical use and designed by an expert in protection against the risks associated with exposure to radiation in accordance with the regulations in force in the country of use For Europe the electric system in the room where the device is installed must comply with the IEC 60364 7 710 standards requiremen...

Страница 12: ... she must wear a leaded apron with thyroid collar f Inform the patient about the risks associated with the exam acquire his her informed consent and archive the document In case of claims or need of technical assistance users in Brazil are required to contact the following email address servico odontologico cefla it Users in the USA market are required to contact Cefla North America Inc 6125 Harri...

Страница 13: ...he device or its parts to the Manufacturer or a Technical Service centre disinfect all the external parts of the device using a specific product see the paragraph Cleaning and disinfection and preferably return it in its original packaging At the end of its lifetime dispose of the device in accordance with the regulations in force It is also advisable to disinfect all the external parts of the dev...

Страница 14: ...ded to use the specific medium level disinfectant STER 1 PLUS CEFLA S C which is compatible with the painted surfaces plastic parts and unpainted metal surfaces Alternatively it is recommended to use products that contain 96 ethanol Concentration maximum 30 g for every 100 g of disinfectant 1 propanol N propanol propyl alcohol N propyl alcohol Concentration maximum 20 g for every 100 g of disinfec...

Страница 15: ... by authorised distributors as per MDEL database 1 8 SAFETY WARNINGS 1 8 1 CONDITIONS OF USE In order to use the device in safe conditions refer to the following paragraphs in the manual 1 8 2 GENERAL SAFETY Do not forget to turn off the main switch on the equipment before leaving the surgery The device is not protected against liquid penetration Class IPX0 common protection The equipment is not s...

Страница 16: ...edure must be carried out before the patient accesses the device The operator must stand at a suitable distance from the moving parts Movements can be stopped at any time by pressing the emergency button During all the movements of the X ray device the operator must closely watch over the patient and if there is a risk of collision between the X ray device and the patient immediately interrupt the...

Страница 17: ... patient s support and of the rotary arm making any linear motor cover a distance shorter than 10 mm and rotatory movements a distance shorter then 2 degrees while the button will remain safely locked Once the emergency has ended turn the button in the direction indicated by the arrow to restore the normal operation 1 8 5 CONDENSATE FORMATION Following strong temperature oscillations condensate ma...

Страница 18: ...ctions for use Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation If such use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Use of accessories transducers and cables other than those specified or provided by the manufacturer of this equipment could resu...

Страница 19: ...s Immunity test IEC 60601 1 2 Test level Level of conformity Electromagnetic Environment Electrostatic discharge ESD IEC 61000 4 2 IEC 60601 1 2 Test level IEC 60601 1 2 Test level Floors must be made of wood concrete or ceramic tiles If floors are covered with synthetic material the relative humidity should be at least 30 IEC 61000 4 4 fast burst electric transients IEC 60601 1 2 Test level IEC 6...

Страница 20: ...t with the following symbol interferences can be caused Recommended distance between the RF portable and mobile communication devices and the device The device is intended for use in electromagnetic environment where RF irradiated disturbances are controlled The customer or the user of the device can prevent electromagnetic interferences by ensuring a minimum distance between RF mobile and portabl...

Страница 21: ...osed Authorised personnel must always be present outside the room until the projection is completed Pay attention not to release the emission button too soon Please note that during an exposure cycle radiation can be emitted several times Wait for the exposure cycle to be completed Always observe the following points Stay at least 2 metres away from the X ray source during exposure For installatio...

Страница 22: ...References for pediatric dose optimisation In order to ensure a safe use of the device in case of examinations with children or small sized patients it is recommended to consult the following resources dedicated to dental radiology and or CBCT technique National guidelines for dental radiology diagnostics in childhood guideline by Italian Ministry of Health Italian language http www salute gov it ...

Страница 23: ...ing the examination before the actual scanning possibility of carrying out examinations with the patient seated to reduce risk of movement presence of an adjustable craniostat to secure the patient s head and allow a correct positioning for 2D projections possibility of setting reduced X ray parameters For selected 2D protocols the CHILD function is available with lower dose profiles as compared w...

Страница 24: ...osition The X ray device can feature a tele X ray arm fitted on the column support The arm houses a cephalostat which keeps the patient position during the exam and the image detector which translates in synchronisation with the X ray source movement At user s choice the X ray device can be equipped with a single image detector thus the operator must position it on the rotary arm for panoramic X r...

Страница 25: ...c images USB Pen Drive including Instruction Manual Drivers and Software for image display The multiple workstation hardware key allowing to use the 3D functions and or the DICOM licenses is optional in the 2D version while it is always included in the 3D version Warranty certificate Arm for tele X rays optional Sensor for tele X ray images optional CBCT detector for the acquisition of 3D images a...

Страница 26: ...port for 3D scans of models impressions X ray templates phantoms for quality checks consistency tests optional Phantom for 2D quality checks optional Phantom for 3D quality checks optional 22 24 medical monitor for image displaying optional 2D or 3D image acquisition workstation optional Hardware keys for the activation of additional multiple workstation licenses 1 5 10 25 50 250 on the LAN networ...

Страница 27: ...ces used for Patient positioning The control panel features two LED lights which indicate the state of the system If the X ray device is on the left LED is blue If the X ray device is in pause mode Standby the LED flashes A Green LED steadily on indicates that the X ray device is ready for the X ray emission hereinafter referred to as Ready status if pressed the remote X ray button makes the X ray...

Страница 28: ...cally A Column upward movement B Column downward movement 4 4 X RAY EMISSION REMOTE CONTROL The system is equipped with a remote control to enable the X ray emission The remote control includes 1 A confirmation button for the X ray emission 2 Two LED lights a Green machine ready to start the emission b Yellow X ray emission in progress When the system enters the Ready status READY the X ray emissi...

Страница 29: ...e is exhaustive even if partial there is no need to repeat the examination thus avoiding subjecting the patient to a further dose of radiation To comply with the safety regulations on ionising radiations for the operator for clarifications see the paragraph on safety against Radiations the operator must be at a distance of at least 2 metres from the X ray device during the emission ...

Страница 30: ... When the status LED is green namely when the machine is in the Ready status READY This button must be kept pressed for all the cycle interval otherwise the movement will stop This simulation can be useful for patients who are particularly emotional children showing the patient what the examination consists of without having to leave him her alone inside the room 4 6 PARKING POSITION To take the m...

Страница 31: ...tioning 5 Execution of the X ray examination 6 Image display and processing 5 1 STARTING THE SYSTEM Turn the device on by operating the power button placed on the rear side near the column base the display will light up and a sound will be emitted If the X ray device is in Standby mode press the CONFIRMATION button to restore its functions Once it has correctly started the LED is blue and steadily...

Страница 32: ...ers AUTO generation of five focusing layers among which the one most suitable to image reconstruction will be automatically selected PAN CHILD PAN FULL Projection for the view of the complete dental arch and of TMJs temporomandibular joints optimised for paediatric version which adapts to child s morphology Optionally it can be limited to HALF PAN RIGHT limited to right lateral HALF PAN LEFT limit...

Страница 33: ...ENT lower and upper incisors UPPER RH DENT 1st arch quadrant UPPER LH DENT 2nd arch quadrant UPPER FRONT DENT upper incisors LOWER RH DENT 4th arch quadrant LOWER LH DENT 3rd arch quadrant LOWER FRONT DENT lower incisors Options available for image reconstruction SINGLE generation of a single focusing layer MULTI generation of several focusing layers AUTO generation of five focusing layers among w...

Страница 34: ...ions at a different angle to obtain a better anatomical visibility TMJ LAT TMJ LAT FULL Lateral projection along the major axis of mandibular condyles of both the temporomandibular joints TMJ LAT RIGHT Lateral projection of the right joint only it scans three sections at a different angle to obtain a better anatomical visibility TMJ LAT LEFT Lateral projection of the left joint only it scans three...

Страница 35: ...m FOV H 19 5 cm x L 26 cm REDUCED STANDARD H 18 x L 20 Z 1 13 cm FOV H 16 5 cm x L 19 cm REDUCED LONG H 18 cm x L 30 cm Z 1 13 cm FOV H 16 5 cm x L 26 cm Options available for dose profile selections LOW DOSE ECO projection with reduced doses and scanning times REGULAR projection with optimal scanning time for obtaining standard resolution images AP PA Antero posterior AP or postero anterior PA cr...

Страница 36: ...access the complete list of the examinations available for that category Select one of the favourite examinations by touching the relevant icon if any to set such examination as CURRENT examination and go to the examination SETTINGS screen a PAN ADULT examination in the example on the side 5 2 3 SETTING AN EXAMINATION FOR CHILDREN To activate examination parameters suitable for a child s build use...

Страница 37: ...favourite examination in the Home Page bar remove the favourite examination from the Home Page 5 2 5 CHOOSING PROJECTION TYPE PAN Category Choosing the PAN examination category will open the EXAMINATION screen where the type of desired examination can be chosen among those available To help the user s choice example images are shown that represent the type of projection to be carried out The types...

Страница 38: ...tero Anterior tele X rays CARPUS carpus tele X rays Once the choice has been made touch NEXT to confirm and go the next screen 5 2 7 SELECTING A REDUCED ANATOMIC REGION The exposure can be limited to specific anatomical regions for the X ray examinations which allow it from the subsequent screen ANATOMIES by touching the boxes which appear on the graphic representation of the anatomical region int...

Страница 39: ...ters according to the preset values for three different profiles low medium high C CUSTOM sets parameters manually Press on the icons and to increase or decrease the dose administered 3 Available OPTIONS based on the type of examination selected particular options can be chosen The options which may appear are SINGLE the projection generates a single focusing layer This option does NOT affect the ...

Страница 40: ...r the EXAMINATION START CONFIRMATION control console will communicate to the user the operations to be carried out to perform the examination This control consists of indicate which devices are required for the patient positioning and how to position them if necessary be prepared to move removable sensors A dedicated screen shows the actions necessary to correctly perform the examinations and thei...

Страница 41: ...m positioning CARPUS Tele X ray support for carpus positioning OPTIONAL Remember to change the disposable infection control sheats before positioning a new patient Before any X ray examination make sure that the patient does not wear metal objects such as glasses removable prosthesis earrings and any other removable metal object at the height of head or neck If a protective apron is used against r...

Страница 42: ...ray device automatically detects the presence of the sensor in the position in which it is inserted and in relation with the type of examination planned if the sensor is not in the position corresponding with the examination the system allows removing and moving it to the correct position The sensor coupling system contains electronic parts and a mechanical lock It is not recommended to remove the...

Страница 43: ...rs PAN sensor CEPH sensors Make sure to fit each sensor on its correct support in units which feature two sensors The two sensors can be distinguished by the height of the black stripe which identifies the area sensitive to X rays See images PAN sensor CEPH sensors ...

Страница 44: ...y the disposable infection control sheath on the bite block Fig 2 3 insert the soft bite into the bite as indicated in the figure Fig 3 4 push the bite until the block of material is ejected Fig 4 Always apply the disposable infection control sheath on the bite block before inserting the soft bite Carry out the normal positioning procedure for the examination making the patient press the soft inse...

Страница 45: ...g the Patient Positioning or the Execution of Examination and anyway before starting the examination make sure that the X ray device is not accidentally hit in this case it is recommended to make the patient exit the machine and reposition the X ray device returning to the Examination Settings screen and repeating the procedure 5 4 1 LASER TRACES The X ray device features four light traces which h...

Страница 46: ...patient s Frankfurt plane is horizontal in tele X ray examinations CEPH Light traces appear when the CONFIRMATION button is pressed for the first time and the X ray device has moved to the patient access position After 30 seconds of inactivity the traces disappear to make them reappear just press one of the buttons and do not press the CONFIRMATION button or if necessary use the suitable switch in...

Страница 47: ...the front support 7 until the pad is fully against the forehead The forehead s pressure on the support will automatically stabilise it b turn the arms 8 towards the patient s temples so that the rubber elements located at the ends of the arches 9 adhere to the cranium anatomy c turn the levers 10 downwards to obtain a good locking At the end of the exposure remember to turn the levers upwards to u...

Страница 48: ... 4 Ask the patient to take a step forward holding the grip on the handles until he she reaches the position shown in the figure 5 Adjust the height of the bite and rotate it inside the mouth asking the patient to bite it as shown in the figure The tip of upper and lower incisors must be in the bite groove The interproximal space of incisors must be in the bite midline 6 The correct positioning of ...

Страница 49: ...head The forehead s pressure on the support will automatically stabilise it B Close the arms until they touch the patient s cranium C Rotate the top levers downward until they are laterally locked 9 Ask the patient to smile in order to show the upper dentition Normally the vertical light trace falls between the canine cusp and the distal part of the upper premolar In case of particular dysmorphias...

Страница 50: ...the nose base on the under nose support as in the figure 4 Check the symmetry of the patient s head using the sagittal vertical trace as a guide check the correct positioning of the Frankfurt plane by overlapping the upper horizontal light trace as shown in the figure If required for the examination and if necessary slightly tilt the patient s head forward to ease the maximum mouth opening 5 Once ...

Страница 51: ...t is not strictly necessary 7 Before pressing the X ray emission button ask the patient to close his her eyes and to remain still 5 4 5 2 FRONTAL TMJ Repeat the steps of the Lateral TMJ examination with the following modification to steps 4 and 6 Do not position the patient s head according to the Frankfurt plane but so that the vertical light trace overlaps the mandibular branch thus passing thro...

Страница 52: ...guide check the correct positioning of the Frankfurt plane by overlapping the upper horizontal light trace as shown in the figure 5 Once the correct orientation has been found lock the craniostat as explained in paragraph 5 4 2 A Push the front support forward until it rests on the patient s forehead The forehead s pressure on the support will automatically stabilise it B Close the arms until they...

Страница 53: ...e the patient access inside the cephalostat The patient s back must be straight and he she must look straight forward Ideally the line between the auditory meatus and the heel centre must be perpendicular to the floor 5 Close earpieces so that they slightly enter the auditory meatuses making sure not to cause discomfort 6 For LATERO LATERAL projections position the patient s head so that the Frank...

Страница 54: ...exit the machine and reposition the X ray device returning to the Examination Settings screen and repeating the procedure The console EXECUTION of examination screen shows the X ray parameters set and the exposure progression The user can see the amount of dose being administered and how much time is left before the examination ends Press the X Ray remote Control to perform the emission and keep i...

Страница 55: ...d to the patient or to another operator NNT provides an automatic guide for the creation of a DVD which includes a redistributable copy of NNT for displaying images NNT Viewer As an alternative it will be possible to export only X ray images in a standard format DICOM 3 0 so that third parties software can be used to consult them With regard to 2D projections once the examination is complete the c...

Страница 56: ...inst radiation make sure that the patient s neck is not covered otherwise an area not exposed to the X ray would be obtained The steps to follow to properly perform a 3D examination are 1 Switching on of system and PC where the acquisition driver is installed 2 Selection of the 3D examination from control console 3 Preparation of the 3D examination 4 Patient positioning 5 3D examination execution ...

Страница 57: ...heck procedure is a service procedure with X ray emission and must be performed WITHOUT PATIENT 3 For instructions see the section Acquisition operations in the dedicated NNT manual It is NOT necessary that the patient accesses the X ray device during the examination selecting procedure but only at the end of the procedure described in this paragraph Choosing the 3D examination category will open ...

Страница 58: ...CTION OF THE AVAILABLE ANATOMICAL REGIONS FOR 3D EXAMINATIONS Depending on the circumstances a reference anatomical model consistent with the examination field chosen will be displayed The DENT case is shown on the side The screen shows the anatomical model in the two Front and Lateral views The central box identifies the field of view FOV and its position with respect to the anatomical model By t...

Страница 59: ...se mode of administration Technical features are set to ensure the best possible quality of the final image minimising the radiation dose to the patient according to the chosen profile LOW DOSE ECO scanning time and X ray parameters are reduced to the minimum necessary for obtaining standard resolution images REGULAR scanning time and X ray parameters are those optimal for obtaining standard resol...

Страница 60: ...the next paragraph 6 3 PREPARATION OF THE EXAMINATION After the EXAMINATION START CONFIRMATION control console will communicate to the user the operations to be carried out to perform the examination This control consists of indicate which devices are required for the patient positioning and how to position them if necessary be prepared to move removable sensors A dedicated screen shows the action...

Страница 61: ...n control sheats before positioning a new patient Before any X ray examination make sure that the patient does not wear metal objects such as glasses removable prosthesis earrings and any other removable metal object at the height of head or neck If a protective apron is used against radiation make sure that the patient s neck is not covered otherwise an area not exposed to the X ray would be obta...

Страница 62: ...y the disposable infection control sheath on the bite block Fig 2 3 insert the soft bite into the bite as indicated in the figure Fig 3 4 push the bite until the block of material is ejected Fig 4 Always apply the disposable infection control sheath on the bite block before inserting the soft bite Carry out the normal positioning procedure for the examination making the patient press the soft inse...

Страница 63: ...ust the motorised column height using keys to facilitate the patient s access Bring the column at the patient s height 3 The patient must grab the handles with both hands and keep a standing position 4 If necessary refine the height of the chin rest using the keys in the control panel lower area and centre the acquisition area characterised by the lower horizontal laser trace which determines the ...

Страница 64: ...ent not to move during the examination to breath slowly and regularly Make all the unnecessary persons move away from the area exposed to radiation and when required go behind the suitable protection The console EXECUTION of examination screen shows the X ray parameters set and the exposure progression The user can see the amount of dose being administered and how much time is left before the exam...

Страница 65: ...d to the patient or to another operator NNT provides an automatic guide for the creation of a DVD which includes a redistributable copy of NNT for displaying images NNT Viewer As an alternative it will be possible to export only X ray images in a standard format DICOM 3 0 so that third parties software can be used to consult them With regard to 2D projections once the examination is complete the c...

Страница 66: ...s procedure consult NNT Acquisition operations Quality control by means of phantom QA Phantom Image resolution line pairs mm 2 5 lp mm Low contrast resolution At least 2 low contrast points can be distinguished Artefacts In the image there must be no artefacts such as visible horizontal lines or halftones Frequency of the check Yearly Use the optional phantom available upon request with the releva...

Страница 67: ...ly reduced and optimized exposure that with a reduction in trajectory time dose still allows the evaluation of the overall oral health of the patient The image on the left shows a typical image with PAN CHILD exposure 7 2 3 TMJ EXAMINATIONS TEMPOROMANDIBULAR JOINT Programs for the X ray of temporomandibular joints TMJ allow a study of the temporomandibular state in the following modes 7 2 3 1 LATE...

Страница 68: ...MAGES Two X ray images are produced with a single scanning of both right and left condyles The entire structure of tempoeromandibular joints is shown in postero anterior view The image on the left shows a typical image with TMJ FRONT exposure on both the condyles 7 2 3 4 FRONT VIEW OF A SINGLE CONDYLE 3 IMAGES Three X ray images are produced with a single scanning of one condyle The entire structu...

Страница 69: ... the left shows a typical image with SIN FRONT exposure 7 2 4 2 LATERAL VIEW The image on the left shows a typical image with SIN LAT exposure 7 2 5 BITEWING EXAMINATIONS The program of crown exposure BiteWing allows an analysis of the structures corresponding to the patient s bite with an orthogonal projection producing 2 to 4 images according to the selected areas The image on the left shows a t...

Страница 70: ...exposure can be limited up to the single quadrants according to the selected areas 7 2 7 CEPH EXAMINATIONS Programs of Ceph exposure are designed to produce tele X ray images typically used for analyses and studies of cephalometry orthodontics gnathology 7 2 7 1 CEPH AP PA The program of Ceph AP PA exposure depending on whether the cephalostat is in the Antero Posterior AP or Postero Anterior PA p...

Страница 71: ...e upper area of the skullcap The image on the left shows a typical image with CEPH LATERAL FULL WIDE exposure which shows the maximum field of view that can be acquired using CEPH LATERAL programs The image on the left shows a typical image with CEPH LATERAL FULL SHORT exposure where only the cranium front part is acquired The image on the left shows a typical image of CEPH LATERAL SHORT where onl...

Страница 72: ...72 OPERATOR S MANUAL EN 7 2 7 3 CEPH CARPUS The program of CEPH carpus exposure allows viewing the carpus bones of the left hand typically used to determine the patient s skeletal age ...

Страница 73: ...Generator frequency 100 180 kHz Maximum continuous input anode power 42 W Maximum deviations from declared values kV 5 mA 10 ms 5 50 ms mAs 10 0 2 mAs Linearity error 0 2 Coefficient of variation 0 05 X ray tube CANON TOSHIBA D 0510SB CEI OPX 105 12 Focal spot size 0 5 mm according to IEC 60336 Anode material Tungsten W Anode inclination 10 CANON TOSHIBA D 0510SB 12 CEI OPX 105 12 Anode thermal ca...

Страница 74: ...rizontal 80 mm Output radiation intensity Output dose 2D 0 18 mGy mAs 70 kV 550 mm 3D 0 085 mGy mAs 90 kV 650 mm Tolerance 30 Source detector distance SID PAN 550 5 mm Source detector distance SID CEPH 1554 8 mm Source detector distance SID CBCT 650 5 mm Generator reference axis ...

Страница 75: ...EN OPERATOR S MANUAL 75 Characteristics of X ray tubes CANON TOSHIBA D 0510SB ...

Страница 76: ...76 OPERATOR S MANUAL EN CEI OPX105 12 ...

Страница 77: ...diation 0 5 m 60 µGy h 1 0 m 15 µGy h 2 0 m 4 µGy h 3 0 m 1 5 µGy h 2 Standard panoramic X ray Dispersed radiation at the average percentage of use or 4 examinations per hour Distance between the rotation axis and the measurement point Circular measurement points Dispersed radiation 0 5 m 12 µGy h 1 0 m 3 0 µGy h 2 0 m 0 8 µGy h 3 0 m 0 3 µGy h 3 3D 10x8 standard regular Dispersed radiation measur...

Страница 78: ...78 OPERATOR S MANUAL EN 8 4 ISODOSE CURVES FOR CBCT EXAMINATIONS 8 5 ISODOSE CURVES FOR PAN EXAMINATIONS ...

Страница 79: ... 6 mm Resolution 5 lp mm PAN projection Primary screen 0 5 mm Pb Pixel size 100 μm Sensor technology CMOS Scintillator material type Direct Deposition CsI Sensor matrix dimensions 1480 x 60 Gray level 14 bit Magnification PAN 1 25 PAN HD Connection Gigabit Ethernet 8 8 TELE X RAY SENSOR FEATURES CEPH Actual sensitive area dimensions 223 x 6 mm Primary screen 0 5 mm Pb Pixel size 100 μm Sensor tech...

Страница 80: ...conditions Temperature 10 70 C Relative humidity between 10 90 Pressure 710 1060 hPa 8 12 PC REQUIREMENTS Workstations directly connected to the X ray acquisition device For the minimum requirements of the workstations directly connected to the X ray acquisition device and indications on where the NNT Station or the NNT Viewer will be installed see the dedicated annex System minimum and recommende...

Страница 81: ... are purely illustrative refer to the plates placed on the device 1 PAN sensor nameplate 2 Laser danger and warning nameplates 3 Generator nameplates 4 CEPH arm nameplate 5 CEPH sensor identification nameplate 6 DHHS and WARNING nameplate 7 Main nameplate 8 Mark nameplate ...

Страница 82: ...n Check the Craniostat correct position 0 22 Open door detected active interlock Check interlock switch unclosed door 0 23 Image not downloaded from the equipment download it on PC or USB before proceeding New exposure required while the previous one has not yet been downloaded 0 24 Wait for confirmation before pressing X ray control pressed before starting the cbct examination procedure For CBCT ...

Страница 83: ...r therefore expressly accepts that the Software may contain errors To this end the User agrees in his own interest to make back up copies of the files data and images regularly and diligently in order to be prepared for any possible malfunctioning of the Software product or of the systems the software is installed in Acceptance that the Software may contain errors is a condition that must be met i...

Страница 84: ...garding compliance of the Software with that described in the electronic documentation made available on line or in any other manner except for the guarantee for the actual storage medium USB PEN DRIVE if this should be damaged or unusable Any other guarantee is excluded even if the Software is installed in or is part of other software applications developed by third parties In addition in relatio...

Страница 85: ...laces the product on the market It being evident that legislative or regulatory modifications are always possible as are changes in the interpretation of regulations and also considering that any modifications and changes would make the Software in possession of the User no longer compliant to such regulations the User is obliged to from time to time ascertain whether the use he intends to make of...

Страница 86: ... for units with Cephalometric arm and removable detector Section Sensor positioning 10 Perform a movement test running the Dummy panoramic procedure making sure the movement on the 3 axes X Y R rotation and translation simultaneously is smooth and without noise See figure 1 next page To perform a dummy cycle namely the simulation of an examination without the emission of X rays select any type of ...

Страница 87: ...Y R rotation and translation simultaneously is smooth and without noise See figure 1 next page To perform a dummy cycle namely the simulation of an examination without the emission of X rays select any type of panoramic X ray examination and reset the unit Once the reset position has been reached press the Reset button and keep it pressed during the entire procedure otherwise the movement will sto...

Страница 88: ...Figure 1 Figure 2 ...

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